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EU-US Mutual Recognition Agreement is operational for the pharmaceutical sector

The Mutual Recognition Agreement (MRA) between the European Union (EU) and the United States (US) covers six industrial sectors, including the recently amended Good Manufacturing Practices (GMP) on pharmaceuticals. In the pharmaceutical sector, the MRA is intended to facilitate the global sourcing of pharmaceuticals and active ingredients while maintaining high standards for consumer safety. On 1 November 2017, the US Food and Drug Administration (FDA) confirmed the capability, capacity and procedures of eight EU member states (Austria, Croatia, France, Italy, Malta, Spain, Sweden and United Kingdom) to conduct GMP inspections, allowing for the MRA, which was negotiated nearly 20 years ago, to come into force. The EU had previously affirmed the capability, capacity and procedures of the FDA earlier this year. The FDA is expected to approve the capability of agencies in the remaining 20 member states over the next two years.

The MRA introduces important efficiencies in an increasing globalized pharmaceutical supply network. For example, nearly 85% of the pharmaceutical products authorized within the EU include at least one manufacturing step outside of the region. The MRA provides a statutory framework for verifying the effectiveness of inspections carried out by other agencies, allowing the parties to rely on each other’s reports and findings for their own cases and investigations.

All stakeholders will benefit from the now-operational MRA:

Agencies: EU and US authorities will be able to optimize the use of their investigation resources, by concentrating their efforts on regions and manufacturing sites where safety concerns suggest a more cautious evaluation.

Patients: By ensuring consistent standards among the US and the various EU member states, patient safety should be enhanced. As the MRA might encourage manufacturers to consider launching products at the same time in the US and the EU, patients will also benefit from better access to innovative medicines.

Manufacturers: The costs and delays associated with duplicative inspections will be eliminated, enabling manufacturers to launch products faster.

The current MRA applies to a wide range of products, including marketed pharmaceuticals for human use, biological products, intermediates, active pharmaceutical ingredients and investigational products. Vaccines and plasma derived pharmaceuticals, as well as veterinary products, may also be included at a later date.

In practice, the US, the EU and its Member States are expected to rely on each other’s factual findings arising out of GMP inspections at manufacturing sites in their respective territories and plan to adopt common databases and other technologies to facilitate access and information sharing. The new system will also feature a proactive alert system, which will allow agencies to quickly exchange information concerning any identified quality defects, recalls, falsified products or potential serious supply shortages. Agencies in one jurisdiction may also request their counterparts in other jurisdictions to conduct specific inspections within their respective territories and may even rely on GMP inspections conducted outside of their respective territories. In the case of such a request, the agency that is the subject of the request is expected to respond in a timely manner, although no hard deadlines are provided.

The MRA further provides that agencies may attend inspections conducted by the other agencies, conduct their own inspection, or refuse to take account of foreign GMP inspections on the grounds that they are either incomplete or inconsistent.

Companies should encourage agencies to use the MRA and feel free to report any improvement they could foresee after the first months of implementation as this should be a tool beneficial to all stakeholders.